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JC Virus (JCV) Quantitative Real-time PCR

Test Code: 3500

Cpt Code:

87799 (x1)

Clinical Utility

JCV is the etiologic agent of progressive multifocal leukoencephalopathy (PML) which is mainly seen in HIV patients, organ transplant patients, and other immunodeficient syndromes. In addition to PML, JCV also causes nephropathy in the renal transplant setting, although with considerably less frequency than BKV. JCV should always be considered in an immunocompromised patient with progressively deteriorating CNS function. Quantitative JCV DNA PCR can be used to detect JCV in CSF in the setting of CNS disease, and blood and urine in the setting of renal dysfunction. Quantitative DNA PCR can be used to track the course of infection as well as monitor response to treatment.

Procedure

Extraction of JCV DNA from specimen followed by amplification and detection using real-time, quantitative PCR. An internal control is added to ensure the extraction was performed correctly and the PCR reaction was not inhibited. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

The primers and probes used in this assay are specific for all known JCV strains based on similarity search algorithms. Additionally, no cross reactivity was detected when tested against adenoviruses, BKV, CMV, EBV, HSV-1, HSV-2, HHV-6 variant A, HHV-6 variant B, HHV-7, HHV-8, parvo B19, SV-40, and VZV.

Causes For Rejection

Specimens beyond their acceptable length of time from collection as listed in the specimen handling or specimen types other than those listed.

Turnaround Time

Same day (within 8 to 12 hours of receiving specimen), Monday through Saturday

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086

Specimen Information

3503 CSF

NY approved.  Assay Range: 72 copies/mL to 1x108 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Store frozen and ship on dry ice for overnight delivery to Viracor-IBT.

3501 plasma

NY approved.  Assay Range: 40 copies/mL to 1x108 copies/mL. Collect 4-5 mL whole blood in EDTA or ACD tube, centrifuge and transfer 2 mL plasma to sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

3510 serum

NY approved.  Assay Range: 40 copies/mL to 1x108 copies/mL. Collect 4-5 mL whole blood in red top tube, centrifuge and transfer 2 mL serum to sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

3502 urine

NY approved.  Assay Range: 151 copies/mL to 1x108 copies/mL. 2 mL sample collected in a sterile urinalysis container then transferred to sterile, screw top tube for shipment (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Viracor-IBT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

PCR tests are performed pursuant to a license agreement with Roche Molecular Systems, Inc.

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